The following data is part of a premarket notification filed by Poonglim Pharmatech Inc. with the FDA for Ez-injec Ldv Sterile Safety Needle.
| Device ID | K210444 |
| 510k Number | K210444 |
| Device Name: | EZ-Injec LDV Sterile Safety Needle |
| Classification | Low Dead Space Needle, Single Lumen, Hypodermic |
| Applicant | Poonglim Pharmatech Inc. 21, Jayumuyeok 1-gil Gunsan, KR |
| Contact | Cho Hee Min |
| Correspondent | Peter Chung Plus Global 300, Atwood Pittsburgh, PA 15213 |
| Product Code | QNS |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-02-16 |
| Summary: | summary |